Controller for an extremity hyperbaric device

ABSTRACT

A controller is operable to selectively supply gas to, and evacuate gas from, regions of a hyperbaric wound treatment chamber. The controller operates to inflate a passage or rib of the device to provide that the device is made sufficiently rigid for inserting a limb therethrough, and inflate an inflatable cuff to create a seal against the limb. The controller also operates to evacuate ambient air trapped within the chamber, and optionally partially evacuate the passage or rib, after the seal is created by the inflatable cuff, and then introduce oxygen into the chamber, and optionally inflate the passage or rib. The cuff, when inflated and creating a seal against a limb, optionally is at least partially within the chamber, and the treatment gas is supplied to the chamber to maintain the seal of the cuff against the limb.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing dates of U.S.Provisional Patent Application No. 60/932,708 filed May 31, 2007 andU.S. Provisional Patent Application No. 61/002,077 filed Nov. 6, 2007,the disclosures of which are hereby incorporated by reference.

BACKGROUND

Hyperbaric chambers are devices which create sealed environments for theapplication of therapeutic gases to hasten healing of lesions or woundson a patient's body. See U.S. Pat. No. 5,060,644, the disclosure ofwhich is incorporated herein by reference. The introduction ofpressurized oxygen into such an encapsulated environment promoteshealing of various types of lesions and wounds. In particular, thetreatment of lesions and wounds with hyperbaric chambers, in conjunctionwith various stimuli, promotes granulation, raises the capillary bloodoxygen pressure and increases expression of angiogenesis related growthfunction VEGF, HB EGI and KGF, thereby stimulating leukocyte functionnecessary to suppress bacterial proliferation. The introduction ofhumidity into hyperbaric chambers can also produce positive results.

When hyperbaric chambers were first introduced for healing lesions andwounds, they encompassed the entire body. As time progressed, hyperbaricchambers became more sophisticated and included multiple functions, andtopical hyperbaric chambers also were developed, such as described inU.S. Pat. No. 5,060,644.

There still exists a need, however, for a hyperbaric wound treatmentapparatus and method for treating a variety of wounds or lesions on apatient's body with high efficacy and a short treatment time.

SUMMARY OF INVENTION

In accordance with one aspect of the invention, a hyperbaric woundtreatment device includes a chamber having an interior and an open endin communication therewith, and an inflatable limb sleeve coupled to thechamber and which can be positioned at least partially within theinterior of the chamber adjacent the open end of the chamber.

In one embodiment of the invention, a method of operating a hyperbaricwound treatment device includes inserting a limb through an inflatablelimb sleeve and into an open end of a chamber of the device, where thesleeve is coupled to the chamber and can be positioned at leastpartially within the chamber at the open end. The method furtherincludes inflating the sleeve to an inflated condition when the limb ispositioned within the sleeve, thereby sealing the sleeve about the limb.

In another embodiment, a hyperbaric wound treatment device includes achamber having an open end, and a means coupled to the chamber forreceiving a limb of a patient therethrough. The means is inflatable froma first condition whereby the means is capable of receiving the limb toa second condition whereby the means forms at least a partial seal aboutthe limb. When in the second condition, the means can be positioned atleast partially within the chamber adjacent the open end of the chamber.

In a further embodiment, a hyperbaric wound treatment device fortreatment of a limb of a patient includes a flexible chamber defining aninterior adapted to receive a portion of a patient's limb to be treatedtherein, where the chamber has an open end in communication with theinterior of the chamber. The device further includes an inflatablesleeve coupled to the chamber adjacent the open end, and the sleeveincludes an outer wall spaced from an inner wall defining an interiorregion therebetween. At least a portion of the sleeve is extendable intothe interior of the chamber adjacent the open end thereof. The sleeve isinflatable between a first condition whereby the patient's limb can beinserted through the sleeve into a portion of the interior of thechamber, and a second condition whereby the sleeve forms at least apartial seal about the patient's limb while received within the chamber.

In another aspect of the invention, a controller for controlling ahyperbaric wound treatment device includes a gas conveyance assemblyoperable for creating a negative pressure, and a control device which iscoupled to the gas conveyance assembly. The control device is operableto control the gas conveyance assembly for providing that a portion ofthe gas conveyance assembly is in fluid communication with the treatmentdevice; and for creating a negative pressure within the treatment deviceby evacuating gas, such as ambient air, at least partially from withinthe treatment device.

In one embodiment, a hyperbaric wound treatment control apparatusincludes a means for creating a negative pressure within at least aportion of a hyperbaric wound treatment device. The apparatus furtherincludes a controller coupled to and operable for controlling the meansfor providing that the means is in fluid communication with the portionof the device; and for creating a negative pressure within the portionof the device by evacuating gas at least partially from within theportion of the device.

In another embodiment, a method of conveying gas to and from ahyperbaric wound treatment device includes creating a negative pressurein a treatment chamber of the device after inserting a limb through anopen end of the treatment chamber and sealing the chamber at the openend. The method further includes evacuating gas at least partially fromwithin the treatment chamber, and supplying a treatment gas to thetreatment chamber following the evacuation of the gas from the treatmentchamber.

In still another embodiment, a method of controlling flow of gas to andfrom a collapsible hyperbaric wound device includes inflating aninflatable rib of the device, which is for retaining the device in arigid state, with a gas at least partially, before inserting a limb intoa treatment chamber of the device having an open end. The method furtherincludes inflating an inflatable sleeve of the device, which is forreceiving the limb of a patient, to an inflated condition for at leastpartially sealing against the limb at the open end of the chamber. Inaddition, the method includes evacuating gas at least partially from atleast one of the chamber and rib, and supplying a treatment gas to thechamber after the evacuating.

In still a further embodiment, a controller for controlling gas flow toand from a collapsible hyperbaric wound treatment device includes first,second and third control valves adapted for coupling to an inflatablesleeve, a treatment chamber and an inflatable rib, respectively, of thedevice. Within the device, the inflatable rib is for retaining thedevice in a rigid state, the treatment chamber includes an open end forreceiving a limb of a patient and the inflatable sleeve is for sealingagainst the limb at the open end of the chamber when the sleeve is aninflated condition. The controller further includes a processor forselectively controlling the control valves and for selectively providingthat at least one of the first, second and third control valves is influid communication with a gas source or a pump. The processor isoperable for controlling the third valve for inflating the rib with agas at least partially, before the limb is received in the chamber; forcontrolling the first valve for inflating the sleeve for at leastpartially sealing the sleeve against the limb at the open end of thechamber; for controlling the second valve for evacuating gas at leastpartially from the chamber based on operation of the pump and after theinflating of the sleeve for sealing the sleeve against the limb; and forcontrolling the second valve for supplying a treatment gas to thechamber from the gas source.

In another aspect of the invention, a hyperbaric wound treatmentapparatus includes a chamber having an interior and an open end incommunication therewith, and an inflatable limb sleeve configured forreceiving a limb and coupled to the chamber. The sleeve can bepositioned at least partially within the interior of the chamberadjacent the open end. The apparatus further includes a gas conveyanceassembly, which is coupled to the sleeve and the interior of the chamberand is for creating a negative pressure, and a control device coupled tothe gas conveyance assembly. The control device is operable forcontrolling the gas assembly for inflating the sleeve to an inflatedcondition for at least partially sealing against the limb adjacent theopen end of the chamber, with the sleeve at least partially within theinterior of the chamber at the open end; and for creating a negativepressure with the interior of the chamber by evacuating gas from theinterior of the chamber, after the inflating of the sleeve.

In a further embodiment, a method of providing a treatment gas to ahyperbaric wound treatment device includes, after inserting a limbthrough an inflatable sleeve and into an interior of a chamber of thedevice, where the chamber has an open end in communication with theinterior and the inflatable sleeve is coupled to the chamber and can bepositioned at least partially within the interior of the chamberadjacent the open end, inflating the limb sleeve to an inflatedcondition for creating at least a partial seal between the limb and thesleeve adjacent the open end, with the sleeve at least partially withinthe interior of the chamber. The method also includes, after creatingthe seal, evacuating at least partially gas from within the interior ofthe chamber, and supplying a treatment gas to the interior of thechamber, following the evacuation of the gas from the interior of thechamber.

Additional features and advantages of the invention will become apparentto those skilled in the art upon consideration of the following detaileddescription of the disclosed embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and features of this invention will bemore fully apparent from a reading of the following detailed descriptionin conjunction with the accompanying drawings in which like referencenumerals refer to like parts, and in which:

FIG. 1 is a perspective view of an exemplary controller in accordancewith one aspect of the present invention.

FIG. 2 is a view of the interior of the controller of FIG. 1.

FIG. 3 is a partial schematic, block diagram of exemplary controlcircuits under control of a control module of a controller in accordancewith an embodiment of the present invention.

FIG. 4 is a flow chart of a process in accordance with an aspect of thepresent invention.

FIG. 5 is a partial schematic, block diagram of a controller coupled toa hyperbaric wound treatment device, in accordance with an aspect of thepresent invention.

FIG. 6 is a schematic illustration of an embodiment of a hyperbaricwound treatment device.

FIG. 7 is an illustration of an embodiment of a portion of thehyperbaric wound treatment device of FIG. 6.

FIG. 8 is a schematic illustration of another embodiment of a hyperbaricwound treatment device.

FIG. 9 is a schematic illustration of an embodiment of a seal for ahyperbaric wound treatment device.

FIG. 10 is a schematic illustration of a topical hyperbaric woundtreatment device for use with a controller in accordance with thepresent invention.

DETAILED DESCRIPTION

FIG. 1 is a perspective view of a hyperbaric controller 10 adapted tocontrol the operations of a flexible hyperbaric wound treatment device,in accordance with an aspect of the present invention. The controller 10is desirably portable and can be easily picked up and moved to differentoperating locations by an operator. A housing 11 for the controller 10includes side panels 12A, 12B, end panels 13A, 13B, a bottom panel (notshown) and a top panel 14. Although the embodiment of the inventiondiscussed below and illustrated in the drawings is a flexible type woundtreatment chamber, it is to be understood that the controller, inaccordance with the present invention, also be may be utilized with arigid type of wound treatment chamber, such as described in U.S. Pat.No. 5,060,644.

Referring to FIG. 1, the top panel 14 has indicators or pilot lights 68,70, 72, which indicate operating modes or cycles such as “fill ribs,”“fill cuff,” and “hyperbaric therapy,” respectively, and switches 26,28, 34 which control the operation of the controller 10 and are labeled“cuff fill,” “stop” and “start,” respectively. Thus, the controller 10includes switches that are easy to understand and easy to use, andindicators that alert the user as to the particular operation beingperformed. In an alternative embodiment, in addition to the pilotlights, the indicators of the controller 10 may be in any other form,such as audio, visual or both.

Referring also to FIG. 2, air solenoid control valves 36, 38, 40 andpressure relief valves 42, 43, 44 are mounted to the rear side panel 12Bof the housing 11. A vacuum pump 41 is mounted to the end panel 13A anda power supply 58, including a power switch 74 and a 120 VAC powersupply cord 23, is mounted to the end panel 13B. The air solenoidcontrol valves can be Clippard MME-3PDS (Clippard Instrument Laboratory,Cincinnati, Ohio), the pressure relief valves can be an AirtrolRV-5300-10-W/K (Airtrol Components Inc. New Berlin, Wis.) and the vacuumpump can be a Medo VP0125-V1005-D2-0511 (Medo USA, Hanover Park, Ill.).In addition to the air solenoid control valves, the controller 10 mayincorporate any type of valve or the like to perform its operations, asknown in the art. Further, in addition to the pressure relief valves,other types of valves may be utilized. In addition to the solenoidsmentioned herein, proportional solenoids may also be utilized.

Still referring to FIG. 2 and also referring to FIGS. 3 and 5, treatmentgas, such as oxygen, from a supply source (not shown) is admitted intothe controller 10 via a port 45 b, which is mounted to the side panel12A, and routed to the supply ports of the respective control valves 36,38, 40. Input and output ports 45 c, 45 d, and input and output portassembly 45 e, are mounted to the side panel 12A and connected to thecontrol valves 38, 36 and 40, respectively. The assembly 45 e includes aconventional pressure sensor 145 e, which is electrically connected to amicroprocessor 60 of the controller 10. Pressure relief valves 42, 43,44 are connected to the flow paths, respectively, between the controlvalves 36, 38 and 40 and the ports 45 d, 45 c and the port assembly 45e. The vacuum pump 41 is connected to the exhaust ports of the aircontrol valves 38, 40. The exhaust ports of the relief valves 42, 43,44, the vacuum pump 41 and the cuff control valve 36 are routed to avent port 45 a mounted to the side panel 12A. Tubing to interconnect theports and port assemblies, the control valves, the relief valves and thepump 41 can be conventional ¼″ diameter tubing. Tubing for the exhaustlines connected to the vent port 45 a can be conventional ⅛″ diametertubing. Any device or configuration may be utilized to control the flowof gas, including air and treatment gas, being introduced into orevacuated from a chamber, a cuff or a rib of a wound treatment device.

Referring to FIGS. 2 and 3, the power cord 23 is fed to a switch 74 andto the power supply module 58 to generate +12V and +5V for poweringelectronic control circuits 90 in the controller 10. Control module 22is attached to the top panel 14 and includes a programmablemicroprocessor 60 which is coupled to the control circuits 90 of thecontroller 10. As discussed in detail below, the microprocessor 60 ofthe control module 22 is operable to control the control circuits 90,which are coupled to the valves 36, 38, 40, to provide that gas may beconveyed to and from a hyperbaric wound device, through the valves 36,38, 40. In one embodiment, the control module 22 can include a portionor all of the electronic circuitry of the control circuits 90 thatconnects to the control valves of the controller 10, and the operationof the microprocessor, the valves and the control circuits incombination can provide for conveyance of gas to and from a hyperbaricwound device. Any type of power configuration or power source may beutilized. For instance, the power source may be a battery.

Still referring to FIG. 3 and further referring to FIG. 5, the controlcircuits 90 are used to control the operation of each of the controlvalves 36, 38, 40 which provide for flow of gas, such as oxygen, to aflexible hyperbaric device 100. The 120 VAC power is applied by the mainpower switch 74 to power the supply module 58, which provides +12 V and+5 V for operating the control circuits 90. The control module 22operates the functions of the controller 10, such as time, sequence,pressure sequence and intermittent compression. Intermittent compressionis determined and regulated by the control module 22, optionally basedon the pressure detected in a chamber 114 of the device 100 by thepressure sensor 145 e, in accordance to techniques well known in theart.

The programmable microprocessor 60 provides for software program controlof the controller 10. Although described in greater detail below, themicroprocessor 60 generally includes instructions for operating thehyperbaric device 100, including a cuff 112, a rib 110 and the chamber114, when in use. In one embodiment, the microprocessor 60 includesinstructions on cycling, and cycles the gas in the chamber 114 of thedevice 100, desirably based on a signal received at B7 representative ofthe pressure in the chamber 114 as detected by the pressure sensor 145e. The microprocessor 60 receives a start signal from the switch 34,which is activated when the operator starts to prepare a patient forhyperbaric therapy. The microprocessor 60 provides output signals atports A2, B1, B2, B3 to control the base of each transistor 62 ₁, 62 ₂,62 ₃, 62 ₄, respectively. In an alternative embodiment, cycling may bedone according to information input by the operator. The operator setsand adjusts the time for the therapy as desired. For example, for deepvein thrombosis (“DVT”), no cycling is performed.

The output current from the output signal ports A2, B1, B2, B3 iscurrent limited with resistors 61 ₁, 61 ₂, 61 ₃, 61 ₄, respectively. Thevalue of each of the resistors 61 ₁, 61 ₂, 61 ₃, 61 ₄ is desirably 1Kohms. Each control relay 52, 54, 56, 57 has a flyback diode 66 tosuppress voltage transients which could otherwise damage themicroprocessor 60. In addition to controlling the relays 52, 54, 56, 57,the microprocessor 60 also controls the three pilot lights “fill ribs”68, “fill cuff” 70 and “hyperbaric therapy” 72. Each of the pilot lights68, 70, 72 indicates to an operator of the controller 10 an operationalcycle in which the controller 10 is actually operating. The pilot lights68, 70, 72 are switched by transistors 62 ₅, 62 ₆, 62 ₇, respectively,in response to an “ON” and “OFF” signal from the microprocessor 60. Themicroprocessor 60 may be Model PIC 16F84A, 8 bit microcontroller, with1K bytes of internal ROM memory storage, manufactured by MicrochipTechnology, Inc. of Chandler, Ariz. The switching transistors 62 ₁-62 ₇are commonly available 2N3904. The control relays may be ModelG2R-1S-ASI-DC12 manufactured by Omron Electronics LLC of Schaumburg,Ill. The microprocessor 60 may be any type of computer, processor or anelectronic component capable of performing instructions stored withinit.

FIG. 6 shows a topical hyperbaric wound treatment device 100, asdisclosed in U.S. Patent Pub. No. 2006/0185670, the disclosure of whichis incorporated by reference, having a main chamber 114 including aninterior 214 and an exterior 216. The chamber 114 is closed at one end218 and open at the other end 220, and sized and shaped to define theinterior 214 for receiving a patient's limb, for example, a leg 222.Adjacent the other end 220 is an inflatable cuff seal 112 for sealingagainst the limb 222.

Referring also to FIG. 7, the chamber 114 is defined by a collapsiblebag including an outer sheet 224 and an inner sheet 226 defining a space225 between the two sheets 224 and 226. The device 100 includes fluidports 120, 121 and 122 which are in communication with the interior ofthe cuff 112, the space 225 and the interior 214 of the chamber 114,respectively, and through which gas can be conveyed based on operationof the controller 10. The ports 45 c, 45 d and port assembly 45 e of thecontroller 10 are connected in fluid communication with the ports 121,120, 122, respectively, of the device 100.

In one embodiment, gas can be delivered by the controller 10 to thespace 225 between the sheets 224, 226 to inflate the device 100 to arigid state and maintain the device 100 in the rigid state when gaspressure in the interior of the chamber 114 is cycled between aboutambient pressure and above ambient pressure. In another embodiment,treatment gas inside the chamber 114 may be cycled by the controller 10between at least about atmospheric or ambient pressure to a pressure ofabout up to 50 mm of mercury above atmospheric or ambient pressure.

Referring to FIG. 6, the device 100 may further include a plurality ofinterconnected pockets 230 or miniature chambers formed between thesheets 224, 226. The pockets can be formed by securing portions of thesheets of material together at selected, discrete locations. The sheetscan be secured together at selected portions by any suitable means, suchas by adhesively sealing the sheets together, heat sealing orultrasonically welding the sheets together at selected, discrete pointsin an array resembling a waffle pattern. The present invention is notlimited to a particular pattern for forming the interconnected pockets230, and other patterns can be utilized.

FIG. 8 shows an additional embodiment of the present invention. Ratherthan utilize interconnected pockets 230, a hyperbaric treatment device210 can have inflatable ribs 110 that extend at least partially alongthe sides of the device 210. In this embodiment, the two sheets 224 and226 may be affixed together in a linear fashion creating long passagesor inflatable ribs 110 between the two sheets 224 and 226. The ribs 110can encircle the chamber 114 entirely or partially, and there may be anynumber of such ribs 110. The ribs 110 may be formed in any of themanners listed previously.

FIG. 4 is a flow chart 75 including operations that the microprocessor60 may perform to control the operation of the controller 10. Forpurposes of illustrating the features of the invention, the operation ofthe controller 10 is described in connection with the hyperbaric device100. Referring to FIG. 4, and also to FIGS. 1, 5 and 6, at block 76 anoperator initiates a hyperbaric bag preparation cycle by turning on themain power switch 74, which initializes the microprocessor 60 andassociated electronic control circuits 90. The operator presses the“start” switch 34, which sends a signal to the microprocessor 60. Asignal is provided at the port B3 to turn-on the rib-fill valve 38, andalso at the port A3 to turn-on the “fill ribs” pilot light 68. Oxygen,another gas, such as nitrogen, or ambient air, is supplied at the port45 c and inflates the ribs 110, with any excess oxygen flowing throughthe rib pressure relief valve 43 to the vent port 45 a. In oneembodiment, the valve 38 may control gas flow to and from theinterconnected pockets 230 of the device 100

Next at block 78, the microprocessor 60 starts a timer for five minutesand checks to determine if the “stop” switch 28 is activated, whichindicates that an operator wishes to arrest the preparation procedure.In the case where the “stop” switch 28 has been pressed, themicroprocessor 60 commands the air solenoid control valves 36, 38 and 40to the rest state, turns off the vacuum pump 41, if it is running, andextinguishes the pilot lights 68, 70 and 72, if they are illuminated.After the five minute timer has expired, in block 80 the microprocessor60 commands the ports B3 and A3 to turn off the rib-fill air solenoidcontrol valve 38 and extinguish the “fill ribs” pilot light 68,respectively.

With the ribs 110 now fully inflated, the patient's limb is placed inthe chamber 114 at block 83 and the “cuff fill” switch 26 is activated.When the signal from the cuff fill switch is received by themicroprocessor 60, the microprocessor 60 provides a signal at the portA2 to turn on the cuff-fill valve 36 and also provides a signal at theport A1 to turn on the “Fill Cuff” pilot light 70. It is to beunderstood that the cuff 112 may be inflated using air from thesurrounding atmosphere, or other gas, such as nitrogen and the like.

Next, at block 85, the microprocessor 60 starts a timer for two minutesand checks to determine if the “stop” switch 28 is activated, whichindicates that an operator wishes to arrest the preparation procedure.After the two minute timer has expired, the microprocessor 60 leavesboth ports A1 and A2 switched on, which maintains oxygen flowing throughthe cuff-fill air solenoid control valve 36 and the valve 45 d, andkeeps the “Fill cuff” pilot light 70 illuminated. Excess oxygen flowingto the cuff 112 is vented by the pressure relief valve 42 and exits thecontroller 10 through the vent port 45 a. With the cuff 112 now fullyinflated, the flexible hyperbaric bag 100 is now sealed to the patient'slimb.

Next, at block 86, the vacuum pump 41 is utilized to remove existingambient air from the chamber 114. In some instances, the inflated ribs110 can withstand this ambient air evacuation and stay rigid.

However, in other instances, depending on the size of the vacuum pumpchosen, it may be advantageous to simultaneously evacuate the gas inboth the chamber 114 as well as the ribs 110. This simultaneousevacuation can occur, because the evacuation of the chamber 114 placespressure on the chamber 114 walls and pulls them inwardly. Although theribs 110 can remain inflated while the chamber 114 is evacuated, it hasbeen found that this can place undue stress on the ribs 110. This stressresults from the ribs 110 trying to stay rigid while the evacuation ofthe chamber 114 pulls the ribs 110 inwardly toward the wound. Therefore,to remove this undue stress on the ribs 110, evacuating the ribs 110 fora short period allows the ribs 110 to be pulled inwardly without the gasin the ribs 110 trying to counteract the pressure on the walls as thechamber 114 evacuation occurs. The ribs 110 and the chamber 114 can beevacuated in a manner such that the walls of the chamber 114 will notcontact the wound. Thus, at block 86, the microprocessor 60 port B1 iscommanded to +5 V, which in turn saturates the junction of transistor 62₄ which engages the relay 57 causing the vacuum pump 41 to startremoving gas from the ribs 110 and also gas from the therapy chamber114. The gas may be evacuated up to about 95% of the gas initiallywithin the chamber 114 prior to the commencement of the evacuation, suchthat about 5% of the gas, such as ambient air, initially within thechamber 114 remains within the chamber 114 following evacuation.

Alternatively, additional gas may be supplied to the ribs 110 toovercome the pressures within the chamber 114 during evacuation.

Next, at block 87, the microprocessor 60 starts a timer for five minutesand checks to determine if the “stop” switch 28 is activated, whichindicates that an operator wishes to arrest the preparation procedure.At block 88, after the five-minute timer has expired, the microprocessor60 commands the port B1 to turn off the vacuum pump 41. Now that theribs 110 have been deflated and the chamber 114 has been evacuated, atblock 89, the microprocessor 60 commands the port B2 to activate therapychamber air solenoid control valve 40, and the port B3 to activate thevalve 38. Treatment gas, such as oxygen, flows from the port 45 b,through the valve 40 and the port assembly 45 e and into the therapychamber 114. In one embodiment, the ribs 110 are simultaneously inflatedwith air or gas when the treatment gas is supplied to the chamber 114.However, in the event that the ribs 110 had not been deflated, in block89, only the chamber 114 is filled with oxygen and the treatment begins.

Next, at block 90, the microprocessor 60 starts a timer for five minutesand checks to determine if the “stop” switch 28 is activated. If duringthis block or at any time during the hyperbaric therapy session, thepressure in therapy chamber 114 exceeds 50 mm Hg above one atmosphere ofpressure (“ATA”) or 810 mm Hg, oxygen is vented by the pressure reliefvalve 44 and exits the control box 10 through the vent port 45 a.

At block 91, after the five minute timer has expired, the microprocessor60 commands the ports B2 and A1 to turn off the air solenoid controlvalve 40 and extinguish the “Fill Cuff” pilot light 70, respectively.The microprocessor 60 also commands port B6 on to illuminate “HyperbaricTherapy” pilot light 72. Then the microprocessor 60 continues todetermine if the “stop” button 28 has been pressed in block 92. Finally,at block 93, if the “stop” button 28 has been depressed because ofeither an emergency situation or the hyperbaric therapy treatment iscompleted, the microprocessor 60 commands ports A2 and B6 to shut offthe oxygen flow to the cuff 112 and extinguish “hyperbaric therapy”pilot light 72. The oxygen in the cuff 112 now vents to the atmospherevia the exhaust port of air solenoid control valve 36, leavingcontroller 10 through the vent port 45 a. Although timers can be usedthroughout, in an embodiment of the present invention, a timer may notbe required or utilized for some or all of the blocks described herein.In the event a timer is not incorporated, depressing the stop button maysimply halt the process currently underway. In another embodiment,instead of timers, event driven sensors, such as pressure sensors, orthe like may be used.

The objects and illustrative embodiments of the hyperbaric therapy arefully disclosed in U.S. Pat. Pub. No. 2006/0185670A1 entitled“Hyperbaric oxygen devices and delivery methods,” the disclosure ofwhich is incorporated herein by reference.

In one embodiment, the controller 10 may also have a built-in safetyfeature should the pressure in the chamber 114 during treatment exceedits preset pressure, for example, a maximum pressure of 100 mm Hg aboveATA, or 860 mm Hg. In such embodiment, referring to FIGS. 3 and 5, thecontroller 10 includes a port B8 connected through a 1K resistor 61 ₈ toa base of a transistor 62 ₈, and a control relay 59 with a flyback diode66 couples the collector of the transistor 62 ₈ to a dump (exhaust) airsolenoid control valve 39. The controller 10 commands the port B8 toopen the valve 39, which is in fluid communication with the portassembly 45 e, when the “Stop” switch 28 is activated, to cause thechamber 114 to automatically decompress to 0 mm Hg and avoid the risk ofa tourniquet effect. The tourniquet effect may be caused by the therapypressure being set above capillary closure in the human body (16-33 mmHg), or if a malfunction occurs, such that the pressure sensor does notoperate correctly or the chamber 114 stays at a constant pressure aboveabout 22 mm Hg. This safety feature of the controller 10 offers benefitsto patients who suffer from chronic wounds, have very fragile vascularsystems in their lower extremities and are at high risk of capillaryclosure. In an alternative embodiment, the controller 10 commands theport B8 to open the valve 39, based on a signal provided by the pressuresensor 145 e, which is representative of the pressure within the chamber114.

In another aspect of the present invention as shown in FIG. 9, the cuff112 of the hyperbaric treatment device 100 can be positioned partiallyor wholly inside the chamber 114 when in an inflated condition.Referring to FIG. 9, the cuff 112 includes a tubular inflatable sleeve240 that can provide a hermetic seal against the limb when the limb isinserted through the sleeve 240 and into the chamber 114. The sleeve hasa length L as well as an inside diameter Id and an outside diameter Od.The sleeve 240 further includes an inside wall 242, an outside wall 244and a side wall 246 that connects the inside and outside walls, 242,244. The inside diameter Id is formed from the inside wall 242, and theoutside diameter Od is formed from the outside wall 244.

The sleeve 240 is inflated using an air valve 248 disposed on the sleeve240. In one embodiment, the valve 248 is coupled in fluid communicationwith the valve 45 d of the controller 10. Air or any suitable gas isintroduced between the inside and outside walls, 242, 244 to inflate thesleeve 240. Prior to inflation, the inside diameter Id is X. Uponinflation, the inside diameter is less than X. This ensures that thesleeve 240 diameter, prior to inflation, is large enough to accommodatea limb sliding through the sleeve 240, but the diameter can be decreasedenough to snugly encircle another portion of the limb that is not fortreatment. In one embodiment, the sleeve 240 is configured to have asufficiently large diameter in a non-inflated or partially inflatedcondition, such that a portion of a limb to be inserted into the chamber114 for treatment can be slid through the sleeve 240, when the sleeve240 is in such condition, without the portion of the limb contacting thesleeve inside wall 242, while providing that the diameter also can bedecreased enough to snugly encircle another portion of the limb that isnot for treatment.

In one embodiment, the outside wall 244 and the side wall 246 may have athickness greater than the thickness of the inside wall 242. Thisdifference in thickness ensures that when the sleeve 240 is inflated,the thicker walls generally resist flexure and maintain their size anddimension, allowing the inside wall 242 to absorb the inflation. Thus,due to its smaller thickness, the inside wall 242 will stretch andaccommodate the inflation, allowing the inside diameter Id to decreaseto a size sufficient to seal against a limb. This also allows the sleeve240 to seal well against any variations in the limb size or shape, suchas a knee or ankle.

In one embodiment, the sleeve wall thicknesses are larger than thethickness of the chamber walls, formed by the sheets 224 and 226. Thisis because the sleeve 240 must withstand the pressures within the sleevedue to inflation of the sleeve 240 and pressure on the outside of thesleeve from the gas in the chamber 114. Thus, the sleeve 240 is acted onby pressures from inside the sleeve 240 and inside the chamber 114. Thepressure within the sleeve 240 is much smaller than the maximum pressurein the chamber 114. Therefore, the pressures internal and external tothe sleeve 240 do not cancel out.

An advantage of placing the sleeve 240 within the chamber 114 is toensure that the incidence of the sleeve 240 sliding off the limb isreduced. The gas inside the chamber 114 places positive pressure on theoutside wall 244 and retains the sleeve 240 in place on the limb. Duringinflation, the sleeve 240 can be inflated up to 1 psi of pressure. Thus,less pressure is required to maintain the sleeve 240 on the limb thanwith other types of wound treatment seals or sleeves placed on theoutside of the chamber 114.

This type of sleeve 240, placed inside the chamber 114, can beincorporated with reusable chambers, chambers having rigid structuressuch as disclosed in U.S. Pat. No. 5,060,644 which is herebyincorporated by reference, as well as single use chambers where thesesleeves 240 can replace the latex seals that are now used. This isespecially advantageous in that some patients have an adverse reactionto latex.

Still referring to FIG. 9, in an alternative embodiment of the device100, the outside wall 244 of the sleeve 240 is attached to an interiorwall surface 249 of the chamber 114. In addition, the sleeve 240 is madeof sufficiently flexible material, such that the sleeve 240 can befolded or rolled into itself, when the sleeve 240 is not inflated orminimally inflated. In one desired embodiment, the sleeve 240 can befolded so that the sleeve 240 is not within the interior 114 of thedevice 100 when the interior 114 is not inflated or minimally inflated.

References to the hyperbaric chamber device 100 are exemplary only andit should be noted that the controller 10 described herein can be usedwith any type of hyperbaric chamber. For example, the controller 10 canbe used with reusable chambers, a topical hyperbaric chamber such as atorso or abdominal chamber or a single use hyperbaric chamber havingseveral internal rings that form a plurality of chambers within thechamber 114. The controller can also be configured for use with chambersthat treat wounds by means of evacuation or chambers that performcompression therapy or a combination of a variety of treatments.

In an embodiment of the present invention, the controller 10 describedherein can be utilized with a topical hyperbaric chamber device 300, asillustrated in FIG. 10. See U.S. Pat. No. 5,154,697, which is alsoincorporated by reference herein. Referring to FIG. 10, the topicaldevice 300 includes a top sheet 302 and a bottom sheet 304 defining aninterior region 314. In addition, the topical chamber 300 includes anopening 306 having a seal 308 for affixing to a patient and incommunication with the region 314. Further, the topical chamber 300includes couplers 310 that connect to the vacuum pump 41 and a valve ofthe controller 10. Once affixed to a patient, the topical chamber 300can be operated by the controller 10 in a manner similar to that of thedevice 100.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and application of the presentinvention. It is therefore to be understood that numerous modificationsmay be made to the illustrative embodiments and that other arrangementsmay be devised without departing from the spirit and scope of thepresent invention as defined by the appended claims.

1. A controller for controlling a hyperbaric wound treatment devicecomprising: a gas conveyance assembly operable for creating a negativepressure; and a control device coupled to the gas conveyance assemblyand operable to control the gas conveyance assembly for: providing thata portion of the gas conveyance assembly is in fluid communication withthe treatment device; and creating a negative pressure within thetreatment device by evacuating gas at least partially from within thetreatment device.
 2. The controller of claim 1, wherein the controldevice is operable to control the gas conveyance assembly for: providingthat the portion of the gas conveyance assembly is in fluidcommunication with a chamber of the treatment device within which a limbof a patient is received; and creating a negative pressure within thechamber by evacuating gas at least partially from within the chamber. 3.The controller of claim 1, wherein the control device is operable tocontrol the gas conveyance assembly for: providing that a gas source andthe treatment device are in fluid communication; and supplying a gasfrom the source under pressure to the treatment device, after theevacuating of gas at least partially from treatment device.
 4. Thecontroller of claim 3, wherein the evacuating is from, and the supplyingof the gas is to, a chamber of the treatment device within which a limbof a patient is received.
 5. The controller of claim 3, wherein thetreatment device comprises a collapsible bag including an inflatable ribfor retaining the bag in a rigid state, and wherein the control deviceis operative for evacuating an interior of the rib.
 6. The controller ofclaim 1, wherein the gas conveyance assembly includes at least one of apump and a control valve.
 7. The controller of claim 1, wherein the gasconveyance assembly includes a valve in fluid communication with thetreatment device.
 8. The controller of claim 7, wherein the valve iscontrollable to provide that the valve is in fluid communication with atleast one of a treatment chamber and a passageway in the treatmentdevice, wherein the control device is operable to control the valve for:creating a negative pressure within at least one of the chamber and thepassageway by evacuating gas at least partially from at least one of thechamber and the passageway.
 9. The controller of claim 8, wherein thetreatment device comprises a collapsible bag and the passageway is aninflatable rib for retaining the bag in a rigid state.
 10. Thecontroller of claim 1, wherein the gas conveyance assembly includes aplurality of ports and is operable for at least one of: supplying a gasunder pressure to the treatment device through a selected at least oneof the ports; and creating a negative pressure in the treatment devicethrough a selected at least one of the ports by evacuating gas at leastpartially from the treatment device through at least one of the ports.11. A hyperbaric wound treatment control apparatus comprising: a meansfor creating a negative pressure within at least a portion of ahyperbaric wound treatment device; a controller coupled to and operablefor controlling the means for: providing that the means is in fluidcommunication with the portion of the device; and creating a negativepressure within the portion of the device by evacuating gas at leastpartially from within the portion of the device.
 12. The apparatus ofclaim 11, wherein the portion is a treatment chamber, and wherein themeans is further for supplying a treatment gas from a gas supply underpressure, and wherein the controller controls the means for supplyingthe treatment gas to the chamber under pressure, following theevacuation at least partially of gas from the treatment chamber.
 13. Theapparatus of claim 12, wherein the gas evacuated from the treatmentchamber is ambient air.
 14. The apparatus of claim 12, wherein thecontroller cycles the treatment gas in the treatment chamber betweenambient pressure and a pressure exceeding ambient pressure.
 15. Theapparatus of claim 11, wherein the treatment device includes a treatmentchamber having an open end and a sleeve for sealing against a limb ofpatent at the open end of the treatment chamber, wherein the means isfurther for selectably conveying gas into and out of the device, andwherein the controller is operable for controlling the means forselectably conveying gas into and out of the treatment chamber and thesleeve.
 16. The apparatus of claim 15, wherein the device comprises acollapsible bag including an inflatable rib for retaining the bag in arigid state; and wherein the controller controls the means for inflatingthe rib before a limb is inserted through the open end into the bag. 17.The apparatus of claim 16, wherein the controller controls the means forat least partially evacuating gas from the rib, before a treatment gasis supplied to the bag.
 18. A method of conveying gas to and from ahyperbaric wound treatment device comprising: creating a negativepressure in a treatment chamber of the device after inserting a limbthrough an open end of the treatment chamber and sealing the chamber atthe open end; evacuating gas at least partially from within thetreatment chamber; and supplying a treatment gas to the treatmentchamber following the evacuation of the gas from the treatment chamber.19. The method of claim 18, wherein the device comprises a collapsiblebag including an inflatable rib for retaining the bag in a rigid state,the method further comprising: inflating the rib; inserting the limbinto the treatment chamber and sealing the treatment chamber at the openend; and evacuating gas from the rib before supplying the treatment gasto the treatment chamber.
 20. The method of claim 19, wherein the bagincludes a sleeve adjacent the open end of the treatment chamber, themethod further comprising: inflating the sleeve for at least partiallysealing the sleeve against the limb.
 21. A method of controlling flow ofgas to and from a collapsible hyperbaric wound device, wherein thedevice includes an inflatable rib for retaining the device in a rigidstate, a treatment chamber with an open end and an inflatable sleeve forreceiving a limb of a patient and sealing against the limb at the openend of the chamber when the sleeve is an inflated condition, the methodcomprising: inflating the rib with a gas at least partially beforeinserting the limb into the chamber; inflating the sleeve for at leastpartially sealing the sleeve against the limb at the open end of thechamber; evacuating gas at least partially from at least one of thechamber and rib; and supplying a treatment gas to the chamber, after theevacuating.
 22. The method of claim 21, wherein the supplying includes:supplying a gas to the rib after the evacuating of the gas from the rib.23. A controller for controlling gas flow to and from a collapsiblehyperbaric wound treatment device, wherein the device includes aninflatable rib for retaining the device in a rigid state, a treatmentchamber with an open end for receiving a limb of a patient and aninflatable sleeve for sealing against the limb at the open end of thechamber when the sleeve is an inflated condition, the controllercomprising: first, second and third control valves adapted for couplingto the inflatable sleeve, the treatment chamber and the inflatable rib,respectively; a processor for selectively controlling the control valvesand for selectively providing that at least one of the first, second andthird control valves is in fluid communication with a gas source or apump, wherein the processor is operable: for controlling the third valvefor inflating the rib with a gas at least partially, before the limb isreceived in the chamber; for controlling the first valve for inflatingthe sleeve for at least partially sealing the sleeve against the limb atthe open end of the chamber; for controlling the second valve forevacuating gas at least partially from the chamber based on operation ofthe pump and after the inflating of the sleeve for sealing the sleeveagainst the limb; and for controlling the second valve for supplying atreatment gas to the chamber from the gas source.
 24. The controller ofclaim 23, wherein the processor is operable: for controlling the thirdvalve for evacuating gas at least partially from the rib based onoperation of the pump, before treatment gas is supplied to the chamber.25. The controller of claim 23, wherein the processor is operable: forcontrolling the third valve for supplying a gas to the rib during orafter the evacuation of gas from the treatment chamber.
 26. A hyperbaricwound treatment apparatus comprising: a chamber having an interior andan open end in communication therewith; an inflatable limb sleeveconfigured for receiving a limb and coupled to the chamber, wherein thesleeve is positionable at least partially within the interior of thechamber adjacent the open end; a gas conveyance assembly coupled to thesleeve and the interior of the chamber and for creating a negativepressure; and a control device coupled to the gas conveyance assemblyoperable for controlling the gas assembly for: inflating the sleeve toan inflated condition for at least partially sealing against the limbadjacent the open end of the chamber, with the sleeve at least partiallywithin the interior of the chamber at the open end; and creating anegative pressure within the interior of the chamber by evacuating gasfrom the interior of the chamber, after the inflating of the sleeve. 27.The apparatus of claim 26, wherein the gas conveyance assembly isoperable for supplying a treatment gas to the interior of the chamberfrom a treatment gas supply, following the evacuating of the interior ofthe chamber.
 28. The apparatus of claim 27, wherein the treatment gas issupplied to the interior of the chamber to maintain the interior of thechamber at a pressure exceeding the pressure within the sleeve in theinflated condition.
 29. The apparatus of claim 28, wherein the pressuremaintained in the interior of the chamber exceeds the pressure withinthe sleeve in the inflated condition, such that the pressure in theinterior of the chamber contributes to the sealing of the sleeve againstthe limb.
 30. The apparatus of claim 26, wherein the sleeve includes anouter wall defining an outer diameter and an inner wall defining aninner diameter, and wherein, in the inflated condition with the limbreceived in the sleeve, the inner wall is in sealing contact with thelimb and the outer wall defines a portion of the interior of thechamber.
 31. The apparatus of claim 30, wherein the outer wall has athickness greater than a thickness of the inner wall.
 32. The apparatusof claim 30, wherein, in the inflated condition of the sleeve, the innerdiameter of the inner wall is less than the inner diameter of the innerwall prior to inflation of the sleeve to the inflated condition and theouter diameter of the outer wall is substantially the same as the outerdiameter of the outer wall prior to inflation of the sleeve to theinflated condition.
 33. The apparatus of claim 26, wherein, when thesleeve is in the inflated condition, a pressure within the sleeve isless than a pressure in the interior of the chamber.
 34. The apparatusof claim 26, wherein the sleeve includes an outer wall and an inner wallforming an interior therebetween, and wherein the gas conveyanceassembly includes a valve means through which a gas is conveyable intoand out of the interior of the sleeve and the chamber, respectively. 35.The apparatus of claim 26, wherein the chamber comprises a collapsiblebag having an opening at the open end of the chamber and sized andshaped to receive the limb and an inflatable rib for retaining the bagin a rigid state, wherein the control device is operable to control thegas conveyance assembly for: inflating the rib at least partially beforethe inflating of the sleeve to the inflated condition.
 36. The apparatusof claim 35, wherein the control device is operable to control the gasconveyance assembly for: supplying a gas to the rib under pressureduring or after the evacuation of gas from the interior of the chamber.37. The apparatus of claim 26, wherein the gas conveyance assemblyincludes at least one of a pump and a control valve.
 38. The apparatusof claim 26, wherein the control device is operable to control the gasconveyance assembly for: supplying a gas from a gas source underpressure to the chamber, after the evacuating of the gas at leastpartially from the interior of the chamber.
 39. A method of providing atreatment gas to a hyperbaric wound treatment device, wherein the deviceincludes a chamber having an interior and an open end in communicationtherewith and an inflatable sleeve coupled to the chamber andpositionable at least partially within the interior of the chamberadjacent the open end, the method comprising: after inserting a limbthrough the sleeve and into the interior of the chamber, inflating thelimb sleeve to an inflated condition for creating at least a partialseal between the limb and the sleeve adjacent the open end, with thesleeve at least partially within the interior of the chamber; aftercreating the seal, evacuating at least partially gas from within theinterior of the chamber; and supplying a treatment gas to the interiorof the chamber, following the evacuation of the gas from the interior ofthe chamber.
 40. The method of claim 39, wherein the chamber comprises acollapsible bag including an inflatable passageway for retaining the bagin a rigid state, the method further comprising: evacuating gas at leastpartially from the inflatable passageway before supplying the treatmentgas to the interior of the chamber.
 41. The method of claim 40, whereinthe inflatable passageway is an inflatable rib.
 42. The method of claim39, wherein the treatment gas is supplied to the interior of the chamberto maintain the interior of the chamber at a pressure exceeding thepressure within the sleeve in the inflated condition.
 43. The method ofclaim 42, wherein the pressure maintained in the interior of the chamberexceeds the pressure within the sleeve in the inflated condition, suchthat the pressure in the interior of the chamber contributes to creatingthe seal between the sleeve and the limb.
 44. The method of claim 39,wherein the sleeve includes an outer wall defining an outer diameter andan inner wall defining an inner diameter, and wherein, in the inflatedcondition with the limb received in the sleeve, the inner wall is insealing contact with the limb and the outer wall defines a portion ofthe interior of the chamber.
 45. The method of claim 44, wherein theouter wall has a thickness greater than a thickness of the inner wall.46. The method of claim 44, wherein, in the inflated condition of thesleeve, the inner diameter of the inner wall is less than the innerdiameter of the inner wall prior to inflation of the sleeve to theinflated condition and the outer diameter of the outer wall issubstantially the same as the outer diameter of the outer wall prior toinflation of the sleeve to the inflated condition.
 47. The method ofclaim 39, wherein, when the sleeve is in the inflated condition, apressure within the sleeve is less than a pressure in the interior ofthe chamber.
 48. The method of claim 39, wherein the chamber comprises acollapsible bag having an opening at the open end of the chamber andsized and shaped to receive the limb and an inflatable rib for retainingthe bag in a rigid state, the method further comprising: inflating therib at least partially before the limb is inserted through the sleeveand into the interior of the chamber.
 49. The method of claim 39 furthercomprising: supplying a gas to the rib under pressure during or afterthe evacuation of gas the interior of the chamber.